Evaluating the Impact of "CHUT OTONOM®" Footwear on the Spatio-temporal Parameters of Walking and the Risk of Falls in Elderly People at High Risk of Falling.

Overview

Footwear is one of the extrinsic factors that can cause falls in older adults. Indeed, ill-fitting or worn shoes or slippers that do not support the foot properly, have slippery soles or high heels can contribute to falls. The quality of footwear is a modifiable risk factor that must be addressed to reduce the risk of falling. Therefore, examining the feet and assessing footwear are an integral part of the clinical evaluation of older adults at risk of falling, Older patients are advised to wear shoes and to limit the use of slippers or slipper socks, which do not provide adequate support for the feet and may increase the risk of falls. In this regard, in November 2020, the French National Authority for Health (HAS) published best practice recommendations entitled "The feet of older people: medical approach and podiatric care." INNOTHERA Laboratories recently designed a new line of shoes, called CHUT OTONOM®, featuring a patented outsole whose effectiveness in terms of stability has been proven in healthy subjects.

Interventions

• Device "CHUT OTONOM®" shoes from Innothera Laboratories
  The patient will be asked to put on, depending on the group to which they have been randomized, Sequence 1: "CHUT OTONOM®" shoes from Innothera Laboratories to perform the Timed Up and Go (TUG) test, the one-leg balance test, and the treadmill recording (GaitRite) for 5 minutes. After a 15-minute rest period, the same measurements will then be taken with their usual shoes.
• Device "CHUT OTONOM®" shoes from Innothera Laboratories
  The patient will be asked to put on, depending on the group to which they have been randomized, Sequence 2: "Their usual shoes to perform the TUG, the one-leg stand test, and the treadmill recording (GaitRite) for 5 minutes. After a 15-minute rest period, the same measurements will then be taken with the "CHUT OTONOM®" shoes from Innothera Laboratories

Primary outcome measures

• Measurement of walking speed (cm/s) using the GaitRite device under two conditions: with Innothera Laboratories' CHUT OTONOM® shoes and with the patient's usual shoes. [Time frame: Duration of each subject's participation: 7 days]

Secondary outcome measures (10)

• Double support time (seconds) [Time frame: Duration of each subject's participation: 7 days]
• Stride length (centimeters) [Time frame: Duration of each subject's participation: 7 days]
• Stride length variability (percentage) [Time frame: Duration of each subject's participation: 7 days]
• Cycle duration variability (percentage) [Time frame: Duration of each subject's participation: 7 days]
• Gait asymmetry (percentage), [Time frame: Duration of each subject's participation: 7 days]
• Timed Up and Go Test scores in single-task and dual-task conditions. [Time frame: Duration of each subject's participation: 7 days]
• Shoe comfort will be evaluated using the following subjective ordinal scale: 1 very uncomfortable, 2 uncomfortable, 3 neutral, 4 comfortable, 5 very comfortable (according to Menant et al., 2008) on D1 and D7. [Time frame: Duration of each subject's participation: 7 days]
• The ease of putting on and taking off shoes will be evaluated using the following modified subjective ordinal scale (Menant et al., 2008): 1 very difficult, 2 difficult, 3 neutral, 4 easy, 5 very easy on D1 and D7. [Time frame: Duration of each subject's participation: 7 days]
• The feeling of stability will be evaluated using the following subjective ordinal scale (Menant et al., 2008): 1 very unstable, 2 unstable, 3 neutral, 4 stable, 5 very stable on D1 and D7. [Time frame: Duration of each subject's participation: 7 days]
• The feeling of security will be evaluated using the following subjective ordinal scale (Menant et al., 2008): 1 always, 2 often, 3 sometimes, 4 rarely, 5 never on D1 and D7 [Time frame: Duration of each subject's participation: 7 days]

Eligibility criteria

Inclusion criteria

• Male or female, 65 years of age or older
• Having fallen at least once in the previous 6 months.
• Patients whose foot morphology corresponds to the sizes available in Innothera Laboratories' "CHUT OTONOM®" shoes (feet with increased volume).
• Patients able to walk 10 meters unaided, without technical or human assistance.
• Patients seen at the "Multidisciplinary Fall Assessment" day hospital at Calmette Hospital, Lille University Hospital.
• Patients who have given their consent to participate in the study (written consent form signed).
• Patients affiliated to a social health insurance scheme (beneficiaries or dependents).

Exclusion criteria

• Presence of a focal motor deficit in the lower limbs from neurological or orthopedic causes (e.g., hemiplegia resulting from a stroke, limb amputation, etc.).
• Inability to give informed consent
• Persons under legal protection (guardianship, curatorship, judicial protection)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Crossover

Masking

Open label

Primary purpose

Prevention

Study locations

France · 1 center

• CHU de Lille — Lille

Identifiers

NCT: NCT07366424 · 2024_0604

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗